<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200408046998N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-30</date_registration>
      <primary_sponsor>Faculty of Allied Health Sciences, The University of Lahore</primary_sponsor>
      <public_title>Evaluate the effect of Health Education on Knowledge, Attitude and Perception Regarding Cervical Cancer and its Screening among Women of Rural Areas of Punjab</public_title>
      <acronym></acronym>
      <scientific_title>Impact of Health Education on Knowledge, Attitude and Perception Regarding Cervical Cancer and Screening Uptake among Women in Rural Areas of Punjab, Pakistan</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>290</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47054</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Two districts of Punjab will be randomly selected on the basis of high literacy and low literacy rate. At first stage, the list of the tehsils will be prepared for all the rural areas of selected districts and then one tehsil will be selected through simple random sampling. Moreover, in next stage, a list will be prepared for all the union councils of selected tehsils. Then, 1/4th union councils will be selected through lottery method. One participant will be selected per house using simple random sampling by balloting from selected union councils. Eligible women will be divided equally in Intervention and control groups by using table of random numbers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Cervical Cancer Prevention. Condition 2: Cervix Cancer Screening.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: A structured health education will be given to the intervention group respondents about cervical cancer awareness and its screening. There will be lecture method and a video will be shown to the participants. Education material will consist of: what is cervical cancer its sign symptoms and risk factors? How is HPV transmitted? HPV screening and prevention methods, what increases or decreases the risk of developing cervical cancer, what is a Pap test and how to schedule a Pap test and follow up on the results, and what does an abnormal Pap test result mean. The women will be educated in batches (29) each. Each batch will be trained for one day over a 2 hour period from 1000 to 1200 hours. Health Education sessions will last for 5 days. Intervention 2: Control group: The control group will receive usual care. This group also receive health education on cervical cancer and its screening after post intervention activities.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzana Iqbal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House No 65, C Block- Valencia Town Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 32182632</telephone>
        <email>farzana.iqbal@live.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Prof. Dr. M Saleem Rana</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1-Km, Defence Road, Bhupatian Chowk, Off Raiwind Road, Lahore.</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35321761</telephone>
        <email>smrmep@gmail.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Married, age from 15-70 years and they are willing to participate in the study.
Women of rural community
No prior hysterectomy
No pap smear test within last three year</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Already diagnosed with any type of cancer
Any family member diagnosed with cancer
All the woman who will be pregnant, hospitalized or diagnosed with any critical health situation
HIV positive or on immunosuppressive treatments
All those who refused to participate in this study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D06</hc_code>
      <hc_code>Z01.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Carcinoma in situ of cervix uteri</hc_keyword>
      <hc_keyword>Encounter for gynecological examination</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: A structured health education will be given to the intervention group respondents about cervical cancer awareness and its screening. There will be lecture method and a video will be shown to the participants. Education material will consist of: what is cervical cancer its sign symptoms and risk factors? How is HPV transmitted? HPV screening and prevention methods, what increases or decreases the risk of developing cervical cancer, what is a Pap test and how to schedule a Pap test and follow up on the results, and what does an abnormal Pap test result mean. The women will be educated in batches (29) each. Each batch will be trained for one day over a 2 hour period from 1000 to 1200 hours. Health Education sessions will last for 5 days.</i_keyword>
      <i_keyword>Control group: The control group will receive usual care. This group also receive health education on cervical cancer and its screening after post intervention activities.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cervical cancer prevention. Timepoint: Before and after eight weeks of intervention. Method of measurement: Measurement will be done by using a questionnaire consisting of demographic variables, knowledge, attitude and perception variables.</prim_outcome>
      <prim_outcome>Cervical Cancer Screening (Pap Smear). Timepoint: Before and after 8 weeks of intervention. Method of measurement: By performing pap smear test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Faculty of Allied Health Sciences, The University of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-02</approval_date>
        <contact_name>Ethics committee of The University of Lahore</contact_name>
        <contact_address>1 - KM Defence Road, Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
